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Table 2 Systematic review: summary of efficacy results

From: Assessing the effectiveness and cost effectiveness of subcutaneous nerve stimulation in patients with predominant back pain due to failed back surgery syndrome (SubQStim study): study protocol for a multicenter randomized controlled trial

Lead author, year and reference

Follow-up

Pain outcome

Other outcomes

Pre-VAS/NRS, mean (SD)

Post-VAS/NRS, mean (SD), P valuea

Percentage pain relief

Burgher [17]

Mean 4.5 months

Not reported

Not reported

Mean 45% (range: 20 to 80%) (n = 10)

All patients reported to be ‘somewhat’ or ‘very satisfied’ with outcome; 1/6 patients reported reduction in opiate intake

Campbell [12]

Mean 12.8 months

Not reported

Not reported

Not reported

0/10 achieved ‘excellent’ outcome on pain relief; 2/10 achieved ‘partial success’ of pain relief; 8/10 ‘failure’ of pain relief

Falco [16]

Mean 3 months

9.1 (1.1) (n = 18)

1.2 (1.0) (n = 18), <0.0001a

Not reported

Pain medication usage dropped in 18/18 patients with 7/18 taking no pain medication; ODI: before treatment, mean 33.6 (SD 6.4) and after treatment, mean 19.7 (9.0)

Paicius [13]

Not reported

6.8 (2.3) (n = 6)

2.5 (0.6) (n = 4), 0.07ab

Not reported

‘All patients experienced a significant….increase in their ability to function’

Sator-Katzenchlager [14]

3 months

FBSS 8.0 (1.4) (n = 37); LBP 8.3 (0.9) (n = 29)

FBSS 3.3 (2.1), <0.0001; LBP 4.2 (2.2) (n = 29), <0.0001

Not reported

Significant reduction in WHO analgesic medication score

Verrills [15, 19]

Mean 7.6 months

7.5 (1.2) (n = 28)

3.5 (2.0) (n = 28), <0.05

Mean 60% 16/23 (70%) ≥50% pain relief

2/23 (7%) increased capacity to perform work; 16/23 (70%) reduced analgesia; 20/23 (87%) ‘satisfied’ or better

Verrills [18, 19]

Mean 7.2 months

7.0 (1.3) (n = 44)

3.7 (2.6) (n = 44), <0.0001ab

Not reported

Significant improvement (P <0.03) in disability as assessed by ODI

Yakovlev [20]

1 and 12 months

7.4 (1.0) (n = 18)

1 month 2.6 (0.8) (n = 18), <0.0001ab; 12 months 1.7 (0.6) (n = 18), <0.0001ab

18/18 (100%) ≥50% pain relief at 1 and 12 months

Decreased or discontinued use of pain medication 16/18 (89%)

  1. a P value for pre/post treatment comparison.
  2. bPaired t test undertaken by authors of the present report.
  3. FBSS failed back surgery syndrome, LBP low back pain, NRS numeric rating scale, ODI Oswestry Disability Index, VAS visual analog scale, WHO World Health Organization.